BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE (+)

    MDR report key: 4795825 · Received May 20, 2015

    Report

    Report Number
    2135225-2015-00033
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 21, 2015
    Manufacturer
    MERZ N AMERICA
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    FAMILY NURSE PRACTITIONER (FNP) INJECTED PT WITH 1.5CC OF RADIESSE(+) TO THE NASOLABIAL FOLDS (NL) AND MARIONETTE LINES ON (B)(6) 2015. PT WAS ALSO INJECTED WITH BOTOX IN FOREHEAD AND GLABELLA ON (B)(6) 2015. BY THE EVENING, ONE OF THE NL FOLD AREAS WAS TENDER SO PT RUBBED IT AND PUT A CLOTH OVER IT. BY FRIDAY, (B)(6) 2015, PT'S SKIN FELT IRRITATED. ON SATURDAY, (B)(6) 2015, ONE NL FOLD AREA "BUBBLED UP" AND STARTED TO SEEP A LITTLE. PT TRIED TO COVER IT WITH MAKEUP. BY SUNDAY, (B)(6) 2015, THE PT SAID IT WAS INFECTED. PT STARTED USING A FRIEND'S KEFLEX. THE PT SAW THE INJECTION FNP ON (B)(6) 2015. THE AREA AROUND NL FOLD WAS ERYTHEMIC WITH FIRMNESS TO THE SKIN. PT HAD A THICK LINEAR SCAB DOWN THE NL FOLD. THE INJECTING FNP CONTINUED PT ON KEFLEX AND TOLD HER TO APPLY TRIPLE ANTIBIOTIC OINTMENT AND AN OCCLUSIVE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329416 RADIESSE (+) INJECTABLE IMPLANT LMH MERZ N AMERICA 100080291

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention BOTOX INJECTED TO GLABELLA AND FOREHEAD